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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05519085




Registration number
NCT05519085
Ethics application status
Date submitted
25/08/2022
Date registered
29/08/2022
Date last updated
15/11/2024

Titles & IDs
Public title
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Scientific title
A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1
Secondary ID [1] 0 0
2023-509859-13
Secondary ID [2] 0 0
CA057-001
Universal Trial Number (UTN)
Trial acronym
SUCCESSOR-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - mezigdomide
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone

Experimental: MeziVd (mezigdomide, bortezomib and dexamethasone) -

Experimental: PVd (pomalidomide, bortezomib and dexamethasone) -


Treatment: Drugs: mezigdomide
Specified dose on specified days

Treatment: Drugs: Pomalidomide
Specified dose on specified days

Treatment: Drugs: Bortezomib
Specified dose on specified days

Treatment: Drugs: Dexamethasone
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
From date of randomization to date of disease progression or death due to any cause (Up to approximately 5 years)
Secondary outcome [1] 0 0
Recommended mezigdomide dose
Timepoint [1] 0 0
Up to 12 Months
Secondary outcome [2] 0 0
Plasma concentrations of mezigdomide
Timepoint [2] 0 0
Up to 134 Days
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
From date of randomization to date of death due to any cause (Up to approximately 5 years)
Secondary outcome [4] 0 0
Overall Response (OR)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Complete Response (CR) or better
Timepoint [5] 0 0
Up to approximately 5 Years
Secondary outcome [6] 0 0
Very Good Partial Response (VGPR) or better
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
Time to Response (TTR)
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
Duration of Response (DOR)
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
Time to Progression (TTP)
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
Time to Next Treatment (TTNT)
Timepoint [10] 0 0
Up to approximately 5 years
Secondary outcome [11] 0 0
Progression-free Survival 2 (PFS-2)
Timepoint [11] 0 0
Up to approximately 5 years
Secondary outcome [12] 0 0
Minimal Residual Disease (MRD) negativity
Timepoint [12] 0 0
Up to approximately 5 years
Secondary outcome [13] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [13] 0 0
Up to approximately 5 years
Secondary outcome [14] 0 0
Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) scores
Timepoint [14] 0 0
Up to approximately 5 years
Secondary outcome [15] 0 0
Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) score
Timepoint [15] 0 0
Up to approximately 5 years

Eligibility
Key inclusion criteria
Inclusion Criteria

- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.

i) M-protein = 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or.

ii) M-protein = 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).

iii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.

* Participants received 1 to 3 prior lines of antimyeloma therapy.
* Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.

i) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.

ii) Participants who progressed while being treated with ixazomib monotherapy maintenance = 6 months prior to the time of starting study treatment are not excluded.

* For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
* Participant has had prior treatment with mezigdomide or pomalidomide.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2033
Actual
Sample size
Target
810
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 0 0
Wollongong Hospital-Illawarra Cancer Care Centre - Wollongong
Recruitment hospital [4] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [8] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4575 - Birtinya
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3065 - Melbourne
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
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Braga
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Lisbon
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Porto
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San Juan
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Romania
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Bucharest
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Romania
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Cluj Napoca
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Iasi
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Illes Balears
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Murcia, Región De
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Málaga
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Cáceres
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León
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Madrid
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Istanbul
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Samsun
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England
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Great Britain
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Greater London
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Leicestershire
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London, City Of
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Barnet
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Newcastle upon Tyne
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Stoke-on-Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.
Trial website
https://clinicaltrials.gov/study/NCT05519085
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05519085